PDS Biotechnology Corp (PDSB) 2025 Q4 法說會逐字稿

Greetings, and welcome to the PDS Biotech fourth-quarter 2025 earnings call. (Operator Instructions) As a reminder, this conference is being recorded.

各位好，歡迎參加 PDS Biotech 2025 年第四季財報電話會議。(接線員指示) 提醒各位，本次會議將被錄音。

I would now like to turn the conference over to your host, Mike Moyer with LifeSci Advisors. Thank you. You may begin.

現在我想把電話會議交給本次主持人，LifeSci Advisors 的 Mike Moyer。謝謝。您可以開始了。

Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's fourth-quarter 2025 results and clinical programs update call. I'm joined on the call today by the following members of the company's management team: Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Kirk Shepard, Chief Medical Officer; and Lars Boesgaard, Chief Financial Officer.

謝謝，接線員。各位早安，歡迎參加 PDS Biotech 2025 年第四季業績與臨床計畫更新電話會議。今天與我一同參與電話會議的公司管理團隊成員包括：執行長 Frank Bedu-Addo 博士；醫務長 Kirk Shepard 博士；以及財務長 Lars Boesgaard。

Dr. Bedu-Addo will begin with an overview of the company's recent highlights and its clinical development program. Dr. Shepard Will review the data and rationale behind the amendment the company recently adopted to its Phase III VERSATILE-003 trial, and Mr. Boesgaard will review the financial results for the quarter ended December 31, 2025. Following management's prepared remarks, we will open the call to questions from covering analysts.

Bedu-Addo 博士將先概述公司近期重點與臨床開發計畫。Shepard 博士將回顧公司近期對第三期 VERSATILE-003 試驗所採納之修訂的數據與理據，而 Boesgaard 先生將回顧截至 2025 年 12 月 31 日止季度的財務結果。在管理層預先準備的發言之後，我們將開放給追蹤本公司的分析師提問。

As a reminder, during this call, we will be making forward-looking statements, which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors as discussed in our filings with the SEC, including our quarterly reports on Form 10-Q and annual report on Form 10-K and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information.

提醒各位，在本次電話會議中，我們將發表前瞻性陳述；此類陳述受多項風險與不確定性影響，可能導致實際結果與這些陳述存在重大差異。任何此類陳述均應結合我們新聞稿中的警示性陳述，以及我們向美國證券交易委員會（SEC）提交之文件中所討論的風險因素一併考量，包括我們的 Form 10-Q 季度報告與 Form 10-K 年度報告，以及本次電話會議中所作的警示性陳述。我們不承擔更新任何此等前瞻性陳述或資訊的義務。

Now I'd like to turn the call over to Dr. Bedu-Addo.

現在我想把電話會議交給 Bedu-Addo 博士。

Thank you, Mike, and good morning, everyone. It's our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical programs. The fourth quarter of 2025 capped a period of important progress for PDS Biotech, marked by meaningful advances across our clinical programs, along with financial discipline and expansion of our intellectual property portfolio. Building on the compelling top line data from our VERSATILE-002 Phase II trial, we believe the VERSATILE-003 protocol amendment we've adopted has the potential to create a more efficient path to accelerated approval. shortening the trial's duration, reducing costs and accelerating our timeline to regulatory submission, while preserving overall survival as the basis for full approval.

謝謝你，Mike，各位早安。我們很高興再次與各位交流，並就我們推進臨床計畫的進展提供這份簡要更新。2025 年第四季為 PDS Biotech 一段重要進展期畫下句點；在此期間，我們的各項臨床計畫均取得具意義的進展，同時維持財務紀律並擴充我們的智慧財產權組合。基於 VERSATILE-002 第二期試驗令人信服的主要數據，我們相信我們已採納的 VERSATILE-003 試驗方案修訂，有潛力打造更有效率的加速核准途徑：縮短試驗期間、降低成本並加快我們向監管機關提交申請的時程，同時保留以整體存活期作為取得完整核准的基礎。

For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a genuinely promising treatment option, and we remain focused on advancing it as efficiently as possible.

對於罹患 HPV16 陽性頭頸癌的患者而言，這是一種未被滿足醫療需求顯著且持續增加的疾病；我們相信 PDS0101 代表一項真正具前景的治療選擇，我們仍專注於以最高效率推進其開發。

In recent weeks, we also announced early results from the National Cancer Institute-led trial investigating PDS01ADC, our investigational IL-12 tumor-targeted immunocytokine at the American Association for Cancer Research, AACR, Special Conference on Prostate Cancer Research.

在最近幾週，我們也在美國癌症研究協會（AACR）前列腺癌研究特別會議上，公布由美國國家癌症研究所（NCI）主導之試驗的早期結果；該試驗正在研究 PDS01ADC——我們的研發中 IL-12 腫瘤標靶免疫細胞激素（immunocytokine）。

In patients with metastatic castration-resistant prostate cancer, the majority of whom had failed at least 2 prior treatments, the combination of PDS01ADC and standard of care docetaxel demonstrated encouraging and durable median progression-free survival or PFS of 9.6 months and a median prostate-specific antigen or PSA decline of 40%. 6 out of 16 patients achieved greater than 50% PSA decline. These findings reinforce the potential of PDS01ADC as an immunocytokine that may be used to activate the immune system against multiple solid tumor types. We are encouraged by the progression-free survival and PSA declines observed in this difficult-to-treat population, and we remain focused on advancing PDS01ADC as a key component of our immuno-oncology pipeline.

在轉移性去勢抗性前列腺癌患者中（其中多數至少曾接受並失敗於 2 種既往治療），PDS01ADC 與標準治療多西他賽（docetaxel）的合併療法，展現出令人鼓舞且持久的無惡化存活期（PFS）中位數 9.6 個月，以及前列腺特異抗原（PSA）中位數下降 40%。16 名患者中有 6 名達到超過 50% 的 PSA 下降。這些發現強化了 PDS01ADC 作為一種免疫細胞激素的潛力，可能可用於啟動免疫系統以對抗多種實體腫瘤類型。我們對於在這個難以治療的人群中觀察到的無惡化存活期與 PSA 下降感到振奮，並將持續專注於推進 PDS01ADC，使其成為我們免疫腫瘤產品線的關鍵組成。

Since we last spoke with you, we also strengthened the intellectual property estate for PDS0101 with new patents granted in the United States and Japan. The new US patents, combined with anticipated biologics exclusivity for PDS0101 extends our market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.

自上次與各位通話以來，我們也透過在美國與日本獲准的新專利，強化了 PDS0101 的智慧財產權布局。新的美國專利，加上預期可取得的 PDS0101 生物製劑專屬權，將我們的市場保護延伸至 2040 年代。日本專利則在主要市場既有保護的基礎上，新增更廣泛的物質組成（composition of matter）權利要求。

To elaborate on progress with our VERSATILE-003 trial, in particular, the data and rationale behind the decision to amend the study protocol, I'll turn the call over to Dr. Kirk Shepard, our Chief Medical Officer.

為了進一步說明我們 VERSATILE-003 試驗的進展，特別是修訂研究方案決策背後的數據與理據，我將把電話會議交給我們的醫務長 Kirk Shepard 博士。

Thanks, Frank, and good morning, everyone. As most of you know, last August, we announced completion of our VERSATILE-002 trial with the final data further supporting the durable clinical benefit of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. The strength of this final data and of the data in the sub-analysis, we announced in September led to our strategic decision to seek an amendment to our VERSATILE-003 trial to include progression-free survival or PFS as a primary endpoint.

謝謝你，Frank，各位早安。如各位多數人所知，去年 8 月我們宣布完成 VERSATILE-002 試驗；最終數據進一步支持 PDS0101 在 HPV16 陽性復發性及／或轉移性頭頸癌中的持久臨床效益。這份最終數據以及我們於 9 月公布之次群分析數據的強度，促使我們做出策略性決定：尋求修訂 VERSATILE-003 試驗，將無惡化存活期（PFS）納入為主要終點。

As you will recall, the VERSATILE-002 trial evaluated PDS0101 plus KEYTRUDA or pembrolizumab in patients with HPV16-positive head and neck cancer. A total of 53 patients were enrolled. The final data showed median overall survival was 39.3 months in patients with PD-L1 combined positive score or TPS of more than or equal to 1. The lower limit of the 95% confidence interval was 23.9 months, and the upper limit was not yet estimable.

各位或許記得，VERSATILE-002 試驗評估的是 PDS0101 聯合 KEYTRUDA（pembrolizumab）用於 HPV16 陽性頭頸癌患者。共納入 53 名患者。最終數據顯示，在 PD-L1 綜合陽性分數（combined positive score）或 TPS 大於或等於 1 的患者中，整體存活期（OS）中位數為 39.3 個月。95% 信賴區間下限為 23.9 個月，上限尚無法估計。

The VERSATILE-002 trial is the first of patients in recurrent metastatic head and neck cancer population to report a median overall survival of almost 40 months. The PFS and survival results had important implications for the original design of our Phase III VERSATILE-003 trial. In the original trial protocol, as recommended by the FDA, median overall survival was the primary endpoint and progression-free survival was a secondary endpoint.

VERSATILE-002 試驗是復發／轉移性頭頸癌患者族群中，首個報告整體存活期中位數接近 40 個月的研究。PFS 與存活結果對我們第三期 VERSATILE-003 試驗的原始設計具有重要意涵。在原始試驗方案中，依 FDA 建議，整體存活期中位數為主要終點，而無惡化存活期為次要終點。

It should be noted that the median overall survival relies on the occurrence of death events and that if a drug works well enough to prevent patient death, it may take a long time to get to the critical data readout. With further increase of the final median overall survival readout from 30 months to 39.3 months in the VERSATILE-002 trial and demonstration of the robustness of the PFS results, we felt we had an opportunity to revise the clinical design to enable a potentially faster readout and opportunity for accelerated approval using PFS as a primary endpoint. To address the potential for an extended trial duration while also abiding with the FDA's recommendation to use median overall survival as a primary endpoint, we approached the FDA to amend the protocol to convert PFS to an earlier interim primary endpoint.

需要注意的是，整體存活期中位數仰賴死亡事件的發生；若一項藥物效果足以防止患者死亡，則可能需要很長時間才能取得關鍵數據讀出。隨著 VERSATILE-002 試驗最終整體存活期中位數讀出由 30 個月提高至 39.3 個月，並證明 PFS 結果的穩健性，我們認為有機會修訂臨床設計，以 PFS 作為主要終點，從而可能更快取得讀出並爭取加速核准的機會。為了在遵循 FDA 建議以整體存活期中位數作為主要終點的同時，也能因應試驗期間可能延長的風險，我們與 FDA 接洽以修訂方案，將 PFS 轉換為較早期的期中主要終點。

Following a productive dialogue with the FDA, we were pleased to announce that following the FDA's standard 30-day wait period since filing, the FDA raised no objections, and we are clear to proceed with the amended protocol. We believe this amendment provides us with an important opportunity to potentially shorten the time to regulatory submission while maintaining median overall survival as the endpoint for full FDA approval. Additionally, we also believe this approach may also accelerate the availability of this promising treatment to the rapidly growing population of HPV16-positive patients in dire need of effective therapy.

在與 FDA 進行富有成效的對話後，我們很高興宣布，在提交後依照 FDA 標準的 30 天等待期內，FDA 未提出任何異議，我們已可明確推進修訂後的試驗方案。我們相信，此項修訂在維持「中位整體存活期」作為取得 FDA 完全核准之主要終點的同時，為我們提供了一個重要機會，有望縮短至法規申請提交的時間。此外，我們也相信，此一做法可能加速讓這項具前景的治療，提供給快速成長且迫切需要有效療法的 HPV16 陽性患者族群。

For added context, I'll point out that some additional factors that help explain why we and our investigators are so excited about our current path forward. First, PDS0101 is the only subcutaneous injection product currently in late-stage development for recurrent and/or metastatic head and neck squamous cell carcinoma, which is more convenient for the patient. Additionally, PDS0101 in combination with KEYTRUDA is the only late-stage head and neck squamous cell carcinoma therapy that requires only 5 doses. Most therapeutic approaches require over 20 doses. Our approach also presents convenient dosing intervals of 3 weeks and 6 months after the fourth dose.

為了提供更多背景，我想指出一些額外因素，以協助說明為何我們與研究人員對目前的前進方向如此振奮。首先，PDS0101 是目前唯一以皮下注射方式給藥、且正處於晚期開發階段、用於復發性及／或轉移性頭頸部鱗狀細胞癌的產品，對患者而言更為便利。此外，PDS0101 與 KEYTRUDA 的合併療法，是唯一僅需 5 次給藥的晚期頭頸部鱗狀細胞癌療法。多數治療方式需要超過 20 次給藥。我們的方法亦提供便利的給藥間隔：在第 4 次給藥後，分別於 3 週及 6 個月進行給藥。

These characteristics of PDS0101, together with the reported tolerability and survival reported to date, make PDS0101 a compelling option for patients. It is, therefore, not surprising that several KOLs and investigators involved in our study and many of the institutions such as the Mayo Clinic, Dana-Farber and Yale Cancer Institute continue to voice their strong support for our approach.

PDS0101 的這些特性，加上迄今所報告的耐受性與存活數據，使 PDS0101 成為對患者極具吸引力的選項。因此，參與我們研究的多位關鍵意見領袖（KOL）與研究者，以及包括梅約診所（Mayo Clinic）、丹娜-法伯癌症研究院（Dana-Farber）與耶魯癌症中心（Yale Cancer Institute）等多家機構，持續表達對我們方法的強力支持，並不令人意外。

HPV16-positive cancers are rapidly increasing in the US and EU due to the poor uptake of the human papillomavirus vaccine and other factors. Along with the unique pathogenesis, physiology of the HPV16-positive cancers and the absence of approved targeted therapies, there is a significant unmet need, we believe that PDS0101 is uniquely positioned to address.

由於人類乳突病毒疫苗接種率偏低及其他因素，HPV16 陽性癌症在美國與歐盟正快速增加。再加上 HPV16 陽性癌症獨特的致病機轉與生理特性，以及缺乏已核准的標靶治療，存在顯著未被滿足的醫療需求；我們相信 PDS0101 具備獨特定位可加以因應。

With that, I'll turn the call back over to Frank.

接下來，我把電話交回給 Frank。

Thank you, Kirk. To Kirk's comments, I would add that as stated by Merck, the subcutaneous version of KEYTRUDA, which was recently approved by the FDA, can be administered by a health care provider in as little as one minute. So a potential combination with subcutaneous PDS0101 may shorten administration time and be more convenient for patients.

謝謝你，Kirk。補充 Kirk 的評論，正如默克所述，近期獲 FDA 核准的 KEYTRUDA 皮下劑型，可由醫療照護提供者在短至一分鐘內完成給藥。因此，與皮下 PDS0101 的潛在合併用藥，可能縮短給藥時間並提升患者便利性。

We are excited about the potential of this therapy for head and neck cancer patients. We are, therefore, confident in the potential of our HPV16-tailored approach and the potential of PDS0101 to ultimately provide a well-tolerated treatment without chemotherapy as an option for the growing population of HPV16-positive patients who currently have no effective therapies for this deadly disease and who will soon become the majority of head and neck cancer patients.

我們對此療法在頭頸癌患者中的潛力感到振奮。因此，我們對以 HPV16 為量身打造的策略，以及 PDS0101 最終有望提供一種耐受性良好、且可作為不含化療之治療選項的潛力充滿信心，藉此服務於日益增加、目前對此致命疾病尚無有效療法、且不久將成為頭頸癌患者多數的 HPV16 陽性患者族群。

Now I will turn it over to Lars for a review of our financial results for the 2025 fiscal year.

現在我將交由 Lars 回顧我們 2025 會計年度的財務結果。

Thanks, Frank, and good morning, everyone. Net loss for the year ended December 31, 2025, was approximately $34.5 million or $0.74 per basic and diluted share, which compares to a net loss of $37.6 million or $1.03 per basic and diluted share for the year ended December 31, 2024.

謝謝你，Frank，各位早安。截至 2025 年 12 月 31 日止年度的淨損約為 3,450 萬美元，或每股基本及稀釋虧損 0.74 美元；相較之下，截至 2024 年 12 月 31 日止年度的淨損為 3,760 萬美元，或每股基本及稀釋虧損 1.03 美元。

Research and development expenses for the year ended December 31, 2025, were $19 million compared to $22.6 million for the year ended December 31, 2024. The decrease of $3.6 million was primarily attributable to decreases in manufacturing costs of $2.5 million and personnel costs of $1.8 million. And those decreases were partially offset by an increase in clinical costs of $0.7 million.

截至 2025 年 12 月 31 日止年度的研發費用為 1,900 萬美元，相較截至 2024 年 12 月 31 日止年度為 2,260 萬美元。減少的 360 萬美元主要歸因於製造成本減少 250 萬美元及人事成本減少 180 萬美元。上述減少部分被臨床成本增加 70 萬美元所抵銷。

General and administrative expenses for the year ended December 31, 2025, were $12.5 million compared to $13.8 million for 2024. The $1.3 million decrease was primarily attributable to a decrease in personnel costs.

截至 2025 年 12 月 31 日止年度的一般及行政費用為 1,250 萬美元，相較 2024 年為 1,380 萬美元。減少的 130 萬美元主要歸因於人事成本下降。

Total operating expenses for the year ended December 31, 2025, were $31.5 million compared to $36.3 million for 2024. Net interest expense was $4.1 million for the year ended December 31, 2025, compared to $2.2 million for the year ended December 31, 2024. The change was primarily due to noncash expenses related to extinguishment of debt as well as lower interest income on our cash balances. The company's cash balance as of December 31, 2025, was $26.7 million.

截至 2025 年 12 月 31 日止年度的營運費用總額為 3,150 萬美元，相較 2024 年為 3,630 萬美元。截至 2025 年 12 月 31 日止年度的淨利息費用為 410 萬美元，相較截至 2024 年 12 月 31 日止年度為 220 萬美元。此變動主要由於與債務清償相關的非現金費用，以及我們現金餘額所產生的利息收入較低。截至 2025 年 12 月 31 日，公司現金餘額為 2,670 萬美元。

And with that, operator, we can open the call to any questions.

接下來，接線員，我們可以開放提問。

(Operator Instructions) Joe Pantginis, H.C. Wainwright.

（接線員指示）Joe Pantginis，H.C. Wainwright。

This is Josh on for Joe. Thanks for taking our questions. So now that you have the amended protocol cleared, could you share what the revised enrollment target is going to look like and how that reduction compares to the original design?

我是 Josh，代 Joe 發言。謝謝讓我們提問。既然修訂後的試驗方案已獲放行，能否分享修訂後的收案目標會是什麼樣子，以及這項縮減與原始設計相比如何？

Josh, thanks a lot. I'll hand it over to Kirk to answer your questions.

Josh，非常感謝。我把問題交給 Kirk 來回答。

Yes, certainly. With the revised protocol, and also the increased median survival and robustness of the PFS in 002, we had a meeting with the FDA, which was a very good dialogue. And at that, we were able to shorten the trial to as much as a year as far as getting the final results. And of course, the PFS will be the interim analysis that will first be available most likely in a period of about 1.5 years. That will allow us to get an accelerated review, as you know, to make the drug available to patients. So with the decrease in the end as well as the increased results from the final analysis of the VERSATILE-002, we were able to shorten the duration with this -- a smaller end for the trial.

好的，當然可以。在修訂後的試驗方案下，加上 002 試驗中位存活期的提升以及 PFS 的穩健性，我們與 FDA 進行了一次會議，對話非常順利。在那次會議中，就取得最終結果而言，我們得以將試驗縮短，最多可縮短至約一年。當然，PFS 將作為期中分析，最有可能在約 1.5 年左右的期間內首先取得。如你所知，這將使我們能夠取得加速審查，以便讓藥物可供患者使用。因此，隨著終點的降低，以及 VERSATILE-002 最終分析結果的提升，我們得以縮短試驗期間——也就是以較小的終點來進行此試驗。

Great. Thank you. And so now with this amended protocol, how should we expect R&D to be for 2026? Do you expect that to be a little bit lower than 2025 now with the smaller trial design?

很好。謝謝。那麼在這個修訂後的試驗方案下，我們應如何看待 2026 年的研發費用？由於試驗設計規模較小，你們是否預期會比 2025 年略低？

Lars, I'll hand over to you.

Lars，我把時間交給你。

Yes. So I think as far as the R&D expenses, we're not providing financial guidance per se. However, of course, once we reinitiate the trial, we do expect cost to pick up. The pickup will be commensurate with the amount of sites that we opened and patient enrollment and so forth. So it's tricky to forecast right now.

是的。我想就研發費用而言，我們本身並未提供財務指引。不過，當然，一旦我們重新啟動試驗，我們確實預期成本會回升。這個回升幅度將與我們開設的研究中心數量、病患入組等因素相匹配。所以目前要預測相當困難。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley Securities。

Good morning, team. Thanks for taking my questions. Could you touch on your plans to handle patients already enrolled prior to the 003 pause as part of your interim analysis and wonder if you remain blinded to those sort of patients? I assume they're continuing to dose on active drug and placebo. And then my follow-up question to the prior question was anything you've learned last year from the execution of Phase III that could inform the enrollment pace from here?

各位早安，團隊。謝謝回答我的問題。能否談談你們計畫如何處理在003暫停之前已入組的病患，將其納入期中分析的一部分？以及我想知道你們是否仍對這類病患維持盲態？我假設他們仍持續接受活性藥物與安慰劑給藥。接著，我對前一個問題的追問是：你們從去年第三期試驗的執行中學到的任何經驗，是否能用來推估接下來的入組速度？

And sorry if I missed that, did you say what the sample size -- what the new sample size for the Phase III is? And are you willing to share any more details on the 2 -- it looks like you have the 2 PFS interim analysis. So I don't know what they are designed to hit on the first versus the second? If you can give any more details, that would be great.

另外，如果我漏聽了很抱歉，你們有提到樣本數嗎——第三期的新樣本數是多少？以及你們是否願意分享更多關於2次——看起來你們有2次PFS期中分析的細節。所以我不確定第一個與第二個分別設計要達成什麼目標？如果能提供更多細節就太好了。

Thanks, Mayank. Kirk, do you want to start?

謝謝你，Mayank。Kirk，你要先開始嗎？

Yes, certainly, I'll do. There were many questions asked there. Well, we -- first, the patients who were started on the trial, they will all continue their treatment as indicated by the protocol. It was discussed with the FDA, and they said it was up to us as far as whether to include or not include these patients in the trial. They just wanted to be stated ahead of the protocol restart.

好的，當然，我來回答。你剛才問了很多問題。嗯——首先，已開始參與試驗的病患，都將依照方案規定繼續治療。我們已與FDA討論過，他們表示是否將這些病患納入試驗分析由我們決定。他們只是希望在方案重新啟動前先行載明。

But these patients will be on the trial as the treatment indicated. They will most likely be put in a special subset of the data that will be included for safety in the intent-to-treat data trial. So they will continue to receive their therapy. Let's see the other parts of the study.

但這些病患將依照試驗所指示的治療持續參與。他們很可能會被放入資料中的一個特殊子集，並在意向治療（intent-to-treat）試驗資料中納入安全性分析。因此他們會繼續接受治療。我們再看看研究的其他部分。

Sorry, could you repeat something else...

抱歉，你能再重複一下其他部分嗎……

Yes. Enrollment pace based on what you saw last year, and I believe there's no competitive trial now enrolling given the other trials that were accepting HPV16-positive are fully enrolled maybe. And then if you can share with us the sample size of the new -- of the study and the interim analysis, PFS analysis that -- what are the underlying assumptions of separation between the 2 arms?

好的。根據你們去年看到的情況，入組速度如何？而且我相信目前沒有競爭性試驗在入組，因為其他接受HPV16陽性的試驗可能都已滿額入組。另外，如果可以的話，請與我們分享這項新——這項研究的新樣本數，以及期中分析、PFS分析——兩個組別之間差異（分離度）的基本假設是什麼？

So the enrollment pace was very good and will continue to be good because we've had a very positive response from the sites that we've gone to, to run the study. As you've mentioned now, there's less competition than was when we first began the trial so that we have a robust recruitment of sites. And we're happy to say, too, even with the pause we had while talking to the FDA, we didn't lose one site. They're all excited by this therapy and ready to begin again. So we're very happy about that.

入組速度非常好，而且會持續良好，因為我們拜訪過的研究中心對執行這項研究反應非常正面。如你所提到的，現在的競爭比我們剛開始試驗時更少，因此我們能夠強而有力地招募研究中心。我們也很高興地說，即使在與FDA溝通期間暫停，我們也沒有失去任何一個研究中心。他們都對這項療法感到興奮，並準備好再次開始。所以我們對此非常滿意。

Also, the fact that we figured out our timelines by looking at the VERSATILE-002 study, which was done at a certain rate. And now we expect even increased rate because most of the sites came back so that the VERSATILE-002 sites are now going to be involved in the 003 study, which is good because they know the workings of the protocol and the product, and we expect to have pretty brisk recruitment of the patients.

此外，我們也透過檢視VERSATILE-002研究（該研究以一定速度完成）來推算我們的時程。而現在我們預期速度會更快，因為多數研究中心都回來了，因此VERSATILE-002的研究中心現在也將參與003研究；這很好，因為他們熟悉方案與產品的運作方式，我們預期病患招募會相當迅速。

Mayank, I hope that answered your questions.

Mayank，希望這回答了你的問題。

I -- sorry to push you, if you can share with us the powering assumptions for the interim PFS and the new sample size for the Phase III.

我——抱歉再追問一下，如果你們能與我們分享期中PFS的檢定力（power）假設，以及第三期的新樣本數。

No. So we haven't made the sample size public yet, but the PFS, again, powered it -- high power to detect changes in -- statistically significant changes in PFS, one at completion of recruitment and the other about 6 months later. So both provide high power to detect statistically significant differences between the 2 arms.

不。我們尚未公開樣本數；但PFS方面，同樣地，我們將其設計為——具備高檢定力，以偵測PFS在統計上顯著的變化：一次在招募完成時，另一次約在6個月後。因此兩次分析都能以高檢定力偵測兩組之間在統計上顯著的差異。

Ladies and gentlemen, that will conclude our question-and-answer session. I'll turn the floor back to Dr. Bedu-Addo for any final comments.

各位女士先生，問答環節到此結束。我將把時間交還給Bedu-Addo醫師作最後結語。

Thank you, operator. Combined with early data from our PDS01ADC program and expanded patient protections extending into the 2040s, we believe we have meaningful opportunities ahead as we continue to execute against our priorities in 2026. We look forward to updating you on our progress. Thank you very much.

謝謝你，接線員。結合我們PDS01ADC計畫的早期數據，以及延伸至2040年代的擴大病患保護，我們相信在2026年持續推進並落實我們的優先事項之際，前方有具實質意義的機會。我們期待向各位更新我們的進展。非常感謝。

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的電話會議到此結束。您現在可以掛斷電話線。感謝您的參與。